UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037950 |
|---|---|
| Receipt number | R000043259 |
| Scientific Title | A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU) |
| Date of disclosure of the study information | 2019/09/06 |
| Last modified on | 2020/03/06 09:43:23 |
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Basic information
Public title
A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Acronym
A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Scientific Title
A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Scientific Title:Acronym
A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the test food on nasal and ocular symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Record during pollen exposure
(the number of sneezes and nose blowing, visual analog scale of nasal blockage, nasal itching, eye itching, watery eyes, throat symptoms, sleepiness and daily life)
Key secondary outcomes
Record after exposure pollen
(the number of sneezes and nose blowing, visual analog scale of nasal blockage, nasal itching, eye itching, watery eyes , throat symptoms, sleepiness, and daily life)
visual analog scale of awaking.
eosinophil of nasal mucus.
Doctor observation of the nasal mucus and the nose
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake I period (test food) - washout period - Intake II period (placebo)
Interventions/Control_2
Intake I period (placebo) - washout period - Intake II period (test food)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 69 years of age
(2) Subjects who complained of nasal and ocular symptoms and judged.
(3) Subjects who are judged as suitable for the study by the investigator.
(4) Subjects who obtained the consent about participation in the study.
(5) Subjects who do not take antiallergic drug account for more than half of whole.
Key exclusion criteria
(1) Subjects who constantly use health food richly containing involvement ingredient
(2) Subjects who routinely take medicine affecting the test result.
(3) Subjects who have severe nasal and eye symptoms affecting judgement of symptoms
(4) Subjects who have a medical treatment (specific desensitization therapy) which may influence the outcome of the study.
(5) Subjects who are engaged in drive a car or operate a hazardous machine.
(6) Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function.
(7) Subjects who have a disease requiring regular medication or a history of serious disease for which medication was required.
(8) Subjects who are liable to cause an allergy related to the study.
(9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(11) Subjects who have participated in other clinical studies at the time of this study start
(12) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(13) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Saito |
Organization
Asama Chemical. Co., Ltd.
Division name
Laboratory
Zip code
103-0001
Address
20-6, Nihonbashikodenmacho, Chuo-ku, Tokyo
TEL
03-3661-6282
saito@asama-chemical.co.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Goto |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
c.goto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Asama Chemical. Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
FURUKAWA Research & Consulting
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043259
